Prosthetic heart valve and delivery apparatus

Patent metadata

Field	Value
Publication number	US-11957582-B2
Application number	US-202117468414-A
Country	US
Kind code	B2
Filing date	Sep 7, 2021
Priority date	Aug 22, 2008
Publication date	Apr 16, 2024
Grant date	Apr 16, 2024

Abstract

A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

First claim

The invention claimed is:

1. An assembly comprising:
a radially collapsible and self-expandable prosthetic heart valve comprising:
an annular metal frame made of a shape-memory material, the frame comprising a plurality of posts extending from an outflow end portion of the frame, wherein each of the posts comprises an axial post portion coupled to the outflow end portion of the frame and a transverse post portion coupled to an end of the axial post portion, wherein the transverse post portion has a greater circumferential dimension than the axial post portion, and wherein the transverse post portion is circumferentially curved and has a concave radially facing inner surface and a convex radially facing outer surface; and
a valve member disposed in an interior of the frame; and

a transvascular delivery apparatus comprising:
a shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a proximal end portion having a frusto-conical outer surface that tapers in a proximal direction from a first diameter to a second diameter that is less than the first diameter, the valve connection portion further comprising an annular recess that receives the transverse post portions; and
a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft, wherein the delivery sheath maintains the prosthetic heart valve in a radially compressed state and maintains the transverse post portions within the annular recess for delivery to a native heart valve region; and

wherein the delivery apparatus is configured to cause relative axial motion between the delivery sheath and the prosthetic heart valve to uncover the prosthetic heart valve and allow the prosthetic heart valve to radially self-expand from the radially compressed state to a radially expanded state, wherein the transverse post portions move radially out of the annular recess when the prosthetic heart valve radially self-expands to release the prosthetic heart valve from the shaft.

2. The assembly of claim 1 , wherein the plurality of posts comprises three posts.

3. The assembly of claim 1 , wherein the transverse post portions each comprise two opposing projections that extend in opposite circumferential directions from the end of the axial post portion.

4. The assembly of claim 3 , wherein the two opposing projections are each circumferentially curved.

5. The assembly of claim 3 , wherein the two opposing projections each have a concave radially facing inner surface and a convex radially facing outer surface.

6. The assembly of claim 1 , wherein the annular recess has an annular inner surface, the inner surfaces of the transverse post portions contact the annular inner surface of the annular recess, and the annular inner surface has a circumferential curvature that matches the circumferential curvature of the inner surface of the transverse post portions.

7. The assembly of claim 1 , wherein the annular recess has an axial width, and the transverse post portions have an axial width that is smaller than the axial width of the annular recess to allow the transverse post portions to sit within the annular recess.

8. The assembly of claim 1 , wherein when the transverse post portions are positioned within the annular recess, the transverse post portions cannot move axially out of the annular recess, and the prosthetic heart valve is restricted axially relative to the delivery apparatus.

9. The assembly of claim 1 , wherein the annular recess is bounded proximally by a proximal wall of the valve connection portion, and the proximal wall restricts the transverse post portions from moving proximally relative to the valve connection portion.

10. The assembly of claim 1 , wherein the annular recess is bounded distally by a distal wall of the valve connection portion, and the distal wall restricts the transverse post portions from moving distally relative to the valve connection portion.

11. The assembly of claim 1 , wherein the valve connection portion further comprises a plurality of axial recess portions that extend distally from the annular recess, and wherein the axial post portions of the posts are positioned within the axial recess portions.

12. The assembly of claim 1 , wherein an axial dimension of the transverse post portions is about equal to the circumferential dimension of the axial post portions.

13. The assembly of claim 1 , the annular recesses is positioned proximal to a majority of the frame.

14. The assembly of claim 1 , wherein the delivery apparatus is configured to move the delivery sheath proximally relative to the prosthetic heart valve to uncover the prosthetic heart valve.

15. The assembly of claim 1 , wherein the assembly is configured to extend through a femoral artery and aorta into the native heart valve region.

16. The assembly of claim 1 , wherein the delivery apparatus further comprises a handle coupled to the shaft and to the delivery sheath, wherein the handle comprises means for moving the delivery sheath proximally relative to the prosthetic heart valve to uncover the prosthetic heart valve and allow the prosthetic heart valve to release from the shaft and radially self-expand to the radially expanded state within the native heart valve region.

17. The assembly of claim 1 , wherein when the prosthetic heart valve is in the radially expanded state, the frame has a curved shape that gradually decreases in diameter from an inflow end of the frame to a reduced diameter section of the frame, gradually increases in diameter from the reduced diameter section to an intermediate section of the frame, and then gradually decreases in diameter from the intermediate section to the outflow end portion of the frame, the intermediate section being axially between the reduced diameter section and the outflow end portion.

18. The assembly of claim 17 , wherein the prosthetic heart valve is implantable in the native heart valve region with the reduced diameter section positioned within an annulus of the native heart valve region, the inflow end extending to an inflow side the annulus, and the intermediate section extending to an outflow side of the annulus.

19. The assembly of claim 18 , wherein the inflow end and the intermediate section are greater in diameter than the annulus so as to assist in retaining the prosthetic heart valve in place in the native heart valve region against natural forces tending to dislodge the prosthetic heart valve in inflow and outflow directions.

20. The assembly of claim 1 , wherein the native heart valve region is a native aortic valve region.

21. The assembly of claim 1 , wherein the valve connection portion comprises a cylindrical portion connected to and extending distally from the proximal end portion of the valve connection portion and a distal end portion that is axially spaced from the cylindrical portion to define the annular recess therebetween.

22. The assembly of claim 1 , wherein the frame comprises a plurality of rows of angled struts interconnected to each other to form a mesh structure, wherein the plurality of rows of angled struts includes an outflow row of angled struts connected to each other at a plurality of outflow apices of the mesh structure, wherein the outflow apices define an outflow end of the mesh structure, wherein the end of each axial post portion of each post is connected to and extends from one of the outflow apices, and

Assignees

• Edwards Lifesciences Corp

Inventors

• Alon David
• Benichou Netanel
• Meiri Oded

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title